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NCT Number: NCT04265092

Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis

Introduction/Objectives: In this observational study, we assessed the benefit following an injection of 200 international units (IU) of incobotulinum toxinA in patients with multiple sclerosis (MS) with spasticity of the triceps surae (TS) at 6 weeks (peak efficacy of toxin) and at 3 months (cancellation of efficacy).

Methods: This study enrolled all MS patients willing to participate with Expanded Disability Status Scale (EDSS) scores of less than 6, who required toxin for management of focal spasticity of the TS. Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MS patients aged over 18 years
  • with gait problems related to spasticity of the triceps surae,
  • walking 10 m in less than a minute,
  • with or without technical assistance,
  • with an EDSS of 6.5 or less
  • triceps surae spasticity of between 1 and 3 on the Modified Ashworth Scale.

Exclusion criteria

  • Comprehension problems preventing the patient from expressing his/her free and informed consent to the study.
  • Intolerance to botulinum toxin;
  • botulinum toxin injection in the previous three months.

Treatment and study plan

Incobotulinum Toxin A

Drug

Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.

Primary outcomes

  1. Spatiotemporal gait parameters

    Time frame: at inclusion

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  2. Spatiotemporal gait parameters

    Time frame: at inclusion

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  3. Spatiotemporal gait parameters

    Time frame: at inclusion

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  4. Spatiotemporal gait parameters

    Time frame: at inclusion

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  5. Spatiotemporal gait parameters

    Time frame: at inclusion

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  6. Spatiotemporal gait parameters

    Time frame: at inclusion

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

  7. Spatiotemporal gait parameters

    Time frame: At six weeks

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  8. Spatiotemporal gait parameters

    Time frame: At six weeks

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  9. Spatiotemporal gait parameters

    Time frame: At six weeks

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  10. Spatiotemporal gait parameters

    Time frame: At six weeks

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  11. Spatiotemporal gait parameters

    Time frame: At six weeks

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  12. Spatiotemporal gait parameters

    Time frame: At six weeks

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

  13. Spatiotemporal gait parameters

    Time frame: At three months

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)

  14. Spatiotemporal gait parameters

    Time frame: At three months

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)

  15. Spatiotemporal gait parameters

    Time frame: At three months

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec)

  16. Spatiotemporal gait parameters

    Time frame: At three months

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec)

  17. Spatiotemporal gait parameters

    Time frame: At three months

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters)

  18. Spatiotemporal gait parameters

    Time frame: At three months

    Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

Secondary outcomes

  1. Six-Minute Walk Test (6MWT)

    Time frame: at inclusion, at 6 weeks, at three months

    The 6 MWT is a simple test which requires a 30-meter course, calm, indoors, flat, in a rectilinear rectangular corridor. The route is marked every 3 meters with colored marks. The U-turn should be viewed with a cone. The purpose of this test is to walk as much as possible for 6 minutes. The score is between 0 meters for a non-ambulatory person and about 900 meters for a healthy subject.

  2. the Multiple Sclerosis Walking Scale (MSWS-12)

    Time frame: at inclusion, at 6 weeks, at three months

    From the numbers circled against these questions, the healthcare professional can calculate the MSWS-12 score. This is done by adding the numbers you have circled, giving a total out of 60, and then transforming this to a scale with a range from 0 to 100. Higher scores indicate a greater impact on walking than lower scores.

  3. the Goal Attainment Scale (GAS) score with determination

    Time frame: at inclusion, at 6 weeks, at three months

    In collaboration with the patient, the doctor define a primary and a secondary objectives, with a specific mark for each: -2: worse than before, -1: no change, 0: objective achieved, 1: result better than expected, 2: unexpected result

  4. The Timed Up and Go test (TUG)

    Time frame: at inclusion, at 6 weeks, at three months

    TUG performance is rated on a scale of 1 to 5, where 1 indicates "normal functioning" and 5 indicates "severe abnormal behavior", according to the individual's perception of the risk of falling (Podsiadlo & Richardson, 1991) . The score consists of the time taken to complete the test, in seconds.

Sponsors and collaborators

Lead sponsor

Pôle Saint Hélier

Other

Registry information

Official study title

Gaitox :Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis an Observational Study on Gait Spatiotemporal Parameters

Acronym: GAITOX

Important dates

Study start
2014
Primary completion
2014
Study completion
2019
First posted
Feb 11, 2020
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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